Notify Sponsor

Once a clinical hold is placed on a commercial IND, the sponsor will be notified immediately by telephone by the division director. For both individual and commercial INDs, the division is required to send a letter within five working days following the telephone call. The letter should describe the reasons for the clinical hold, and must bear the signature of the division director (or acting division director).

The sponsor may then respond to CDER by sending an "IND CLINICAL HOLD RESPONSE" letter to the division. To expedite processing, the letter must be clearly identified as an "IND CLINICAL HOLD RESPONSE" letter.

The division then reviews the sponsor's response and decides within 30 days as to whether the hold should be lifted. If the division does not reply to the clinical hold response within 30 calendar days, the division director will telephone the sponsor and discuss what is being done to facilitate completion of the review.

If it is decided that the hold will not be lifted, the hold decision is automatically sent to the office director for review. The office director must decide within 14 calendar days whether or not to sustain the division's decision to maintain the clinical hold. If the decision is made to lift the hold, the division telephones the sponsor, informs them of the decision, and sends a letter confirming that the hold has been lifted. The letter will be sent within 5 working days of the telephone call. However, the trial may begin once the decision has been relayed to the sponsor by telephone.

For more information, see MAPP 6030.1, "IND Process and Review Procedures".

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.